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Zhejiang Haisheng Medical Device Co., Ltd.: FDA-registered device maker in Shaoxing Zhejiang, China, 3 510(k) clearances

Name: Zhejiang Haisheng Medical Device Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhejiang Haisheng Medical Device Co., Ltd. is registered with the FDA (registration 3008693658) in Shaoxing Zhejiang, China. It lists 21 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 31, 2016. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3008693658
Address: No.8, ZhenYuan Road Yuecheng District, Shaoxing Zhejiang, China, 312071
Owner or operator: ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. (9075500)
Roles: Contract manufacturer, Manufacturer
First device listed: July 22, 2005
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Absorbent, Carbon-Dioxide	CBL	1	Manufacturer	accessdata.fda.gov
Adaptor, Holder, Syringe	IQG	1	Manufacturer	accessdata.fda.gov
Airway, Nasopharyngeal	BTQ	1	Manufacturer	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	1	Manufacturer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 31, 2016	K152472	Disposable Pressure Transducer	DRS	Substantially Equivalent	Zhejiang Haisheng Medical Device Co., Ltd.	accessdata.fda.gov
December 18, 2015	K151498	Breathing circuit bacterial/viral filter	CAH	Substantially Equivalent	Zhejiang Haisheng Medical Device Co., Ltd.	accessdata.fda.gov
May 13, 2004	K033008	AIR SAFETY HEPA AND NON-HEPA FILTERS	CAH	Substantially Equivalent	Air Safety, Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 31, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.